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As part of the Penumbra System, the Reperfusion Catheters and Separators are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

As part of the Penumbra System, the Penumbra 3D Revascularization Device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

As part of the Penumbra System, the Penumbra Sterile Aspiration Tubing is indicated to connect the Penumbra Reperfusion Catheters to the Penumbra Aspiration Pump.

The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.

The Penumbra System Reperfusion Catheter Penumbra JET 7 with Xtra Flex technology (JET 7 Xtra Flex) is a component to the currently available Penumbra System. The JET 7 Xtra Flex delivers aspiration from the Aspiration Pump directly to the site of occlusion to assist in the removal of thrombus from the neurovasculature. The devices are provided sterile, non-pyrogenic, and intended for single use only.

The Penumbra System Penumbra JET 7MAX is an additional configuration to the currently available Penumbra System. The MAX Delivery Device is an optional accessory for use with the JET 7 Xtra Flex and is removed prior to aspiration.

This FDA 510(k) summary does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The document explicitly states:

• "There are no differences in technological characteristics between the subject device and predicate device." (Section 1.6)
• "There are no differences in technological characteristics between the subject and predicate devices and therefore no verification and validation studies were required." (Section 1.7)

This means the submission is based on the substantial equivalence principle, asserting that the new device (Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)) is largely identical to previously cleared predicate devices, and therefore does not require new performance data to demonstrate safety and effectiveness. The changes made were solely labeling changes for clarity.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting new performance data against acceptance criteria.

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